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Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00171522
Enrollment
52
Registered
2005-09-15
Start date
2005-05-31
Completion date
2005-09-30
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Constipation, Tegaserod, Polyethylene Glycol 3350, PEG

Brief summary

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

Interventions

DRUGTegaserod and Polyethylene Glycol 3350

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years

Inclusion criteria

* Females aged 18 to 64 years of age * Patients with constipation as defined by the Rome II criteria

Exclusion criteria

* Patients who have been previously been treated with tegaserod and/or PEG 3350 * Evidence of cathartic colon or a history of laxative abuse or laxative dependence * History of fecal impaction which necessitated surgical intervention * Patients with clinically significant abnormal TSH levels at screening * Women who are pregnant or breast feeding Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026